Primary Tumor Research and Outcomes Network

AO Innovation Translation Center1,350 enrolled

Overview

This project aims to establish a network of spine oncology centers dedicated to prospective multicenter research of patients diagnosed with a primary tumor of the spine and will include a comprehensive prospective clinical database which will serve as a shared research platform. Demographic, clinical, diagnostic, and therapeutic variables will be used to answer questions about survival and local recurrence, as well as questions about adverse events (AEs), morbidity data, and health-related quality of life (HRQOL) outcomes.

Objective: To prospectively investigate variables (clinical, diagnostic, and therapeutic) in patients diagnosed with primary spinal column and cord tumors that are associated with: * survival * local recurrence * morbidity data * patient reported outcomes Outcome measures: Variables applicable to primary spinal column tumor patients which will be collected in the registry include: * Patient details * Treatment status * Details of previous treatment * Diagnosis and biopsy types * Tumor details * Oncological staging * Symptoms * Treatment details * Imaging information We aim to collect the following outcome measures: * Overall survival data * Local disease recurrence data * Morbidity data * Patient reported outcomes: * Euroquol-5D-3L, EQ-5D-Y (if applicable) * Euroquol EQ-5D VAS - Quality of Life * Neck pain numeric rating scale (NRS) * Arm pain NRS * Back pain NRS * Leg Pain NRS * SF-36 version 2 * SOSG Outcome Questionnaire (SOSGOQ) v1.0 and v2.0 * Surverys on patient expectations and satisfaction

Study Type

OBSERVATIONAL

Enrollment

1,350

Conditions

Spinal Column Tumor

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion criteria * Patient with a current primary spine tumor or history of a primary spine tumor, including tumors within or surrounding the spinal column and/or spinal cord. This includes extradural tumors, intramedullary tumors (i.e. astrocytomas, ependymoma, etc.) and extramedullary tumors (i.e. meningiomas, neurofibromas, schwannomas, etc.). * Informed consent obtained, i.e.: * Ability to understand the content of the patient information/ICF * Willingness and ability to participate in the registry according to the Registry Plan (RP) * Signed and dated EC/IRB approved written informed consent OR * Written consent provided according to the IRB/EC defined and approved procedures for patients who are not able to provide independent written informed consent Exclusion Criteria: \- Patient diagnosed with a metastatic tumor of the spine.

Locations (19)

University of California

Los Angeles, California, United States

Outcomes

Primary Outcomes

Overall survival data

FU visits will be scheduled and performed according to the local standard of care and at each scheduled visit the patient's survival will be documented. In case a patient misses a scheduled visit it will be assessed if the patient is still alive

Time frame: From the date of enrollment until the date of dropout (ie. consent withdrawal, lost-to follow-up or death) which can be up to 25 years

Local disease recurrence data

At first prospective treatment and every FU visit, each patient, regardless of which stage they are at in their treatment, will be evaluated for local disease recurrence. Patients that are classified as "non-virgin" will be evaluated for local disease recurrence also at baseline.

Time frame: From the date of enrollment until the date of dropout (ie. consent withdrawal, lost-to follow-up or death) which can be up to 25 years

Perioperative morbidity data

Complications will be assessed by evaluating the patient's medical files from the time treatment was initiated until the day of follow-up. Intraoperative complications: (Airway/ventilation; Allergic reaction; Anesthesia related; Bone implant interface failure requiring revision; Cardiac; Cord injury; Dural tear; Hardware malposition requiring revision; Hypotension ; Massive blood loss ; Nerve root injury; Pressure sores; Vascular injury; Visceral injury; Other). Pre-/post treatment complications: (Cardiac arrest/failure/arrhythmia; Construct failure with loss of correction; Construct failure without loss of correction; CSF leak/meningocele; Deep vein thrombosis; Deep wound infection; Delirium; Dysphagia; Dysphonia; GI bleeding; Hematoma; Myocardial infarction; Neurologic deterioration; Non-union; Pneumonia; Postoperative neuropathic pain; Pressure sores; Pulmonary embolism; Superficial wound infection; Systemic infection; Urinary tract infection; Wound dehiscence; Other)

Time frame: From the date of enrollment until the date of dropout (ie. consent withdrawal, lost-to follow-up or death) which can be up to 25 years

Secondary Outcomes

Central Contacts

Felix Thomas, PhD

CONTACT

+41 79 671 47 98 felix.thomas@aofoundation.org

Mariana Cabeleira

CONTACT

+41 79 671 47 98 mariana.cabeleira@aofoundation.org

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

UCSF Medical Center

San Francisco, California, United States

RECRUITING

Johns Hopkins University School of Medicine

Baltimore, Maryland, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, United States

RECRUITING

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

WITHDRAWN

Memorial Sloan Kettering Cancer Center

New York, New York, United States

RECRUITING

Rhode Island Hospital

Providence, Rhode Island, United States

RECRUITING

The University of Texas M.D. Anderson Cancer Center

Houston, Texas, United States

RECRUITING

University of Queensland, School of Medicine

Brisbane, Australia

WITHDRAWN

...and 9 more locations

Euroqol EQ-5D-3L or Euroqol EQ-5D-Y (for patients <16y)

The EuroQOL group developed a standardized instrument for use as a measure of health outcome. Applicable to a wide range of health conditions and treatments, it contains 5 questions and provides a simple descriptive profile and a single index value for health status. EQ-5D is designed for self-completion by respondents and is ideally suited for use in mailed surveys, in clinics and face-to-face interviews. It is cognitively simple, taking only a few minutes to complete. Instructions to respondents are included in the questionnaire.

Time frame: From the date of enrollment until the date of dropout (ie. consent withdrawal, lost-to follow-up or death) which can be up to 25 years

Pain Numeric Rating Scale

It will be assessed for neck, back, leg and arm. The Pain NRS is an 11-point horizontal scale where the end points are the extremes of no pain (0) and pain as bad as it could be, or worst pain (10). It measures subjective intensity of pain and the patient rates his/her overall or average daily pain.

Time frame: From the date of enrollment until the date of dropout (ie. consent withdrawal, lost-to follow-up or death) which can be up to 25 years

SF-36 version 2

It is a multipurpose, short-form health survey with 36 questions. It yields an eight-scale profile of scores: 1) limitations in physical activities because of health problems; 2) limitations in social activities because of physical or emotional problems; 3) limitations in usual role activities because of physical health problems; 4) bodily pain; 5) general mental health (psychological distress and well-being); 6) limitations in usual role activities because of emotional problems; 7) vitality (energy and fatigue); and 8) general health perceptions. In addition, two composite scores are constructed using factorial modeling, one for physical health (Physical Composite Score - PCS) and one for mental health (Mental Composite Score - MCS). A scoring algorithm is available using linear T-score transformation that translates scores using population based norms into scores with mean = 50 and standard deviation = 10. The algorithm is available for all 8 subscales as well for the PCS and MCS.

Time frame: From the date of enrollment until the date of dropout (ie. consent withdrawal, lost-to follow-up or death) which can be up to 25 years

Spine Oncology Study Group Outcome Questionnaire

This is a new HRQOL outcome tool which was developed specifically for metastatic spine disease. It is currently available in English and Hungarian. It contains 20 items representing all four domains of the International Classification of Function and Disability. Additionally, there are seven follow-up questions referring to treatment satisfaction. It is made up of five domains: physical function, neural function, pain, mental health, and social function. During the first phase of this registry, patients completed the SOSGOQ version 1.0. The English SOSGOQ version 2.0 was released in January 2018 and will be used

Time frame: From the date of enrollment until the date of dropout (ie. consent withdrawal, lost-to follow-up or death) which can be up to 25 years

Survey on patient expectation

A survey on the patient's expectation regarding the surgery. Only applicable for patients that receive surgical treatment.

Time frame: Prior to surgical treatment

Survey on patient satisfaction

A survey on the patient's satisfaction post-surgery. Only applicable for patients that receive surgical treatment.

Time frame: After surgical treatment until the date of dropout (ie. consent withdrawal, lost to follow-up or death) which can be up to 25 years